Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability

Samenvatting

The Food and Drug Administration (FDA) is required, under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), to report annually in the Federal Register on the status of postmarketing study commitments made by applicants of approved drug and biological products. This is the agency's report on the status of the studies applicants have agreed to or are required to conduct.